On 4 February 2015, the German Ministry of Justice published a new draft law specifically aimed to combat corruption in the healthcare sector. Key element of the draft legislation will be a newly defined criminal offence that will be inserted as a new Section 299a of the German Criminal Code (StGB). This new criminal offence sanctions active and passive bribery of a wide range of healthcare professionals – not only of medical doctors.
The envisioned new § 299a StGB would significantly sharpen the German anti-corruption laws as far as interactions between life sciences companies with medical doctors and other healthcare professionals are concerned. The criminal culpability would apply to both the healthcare professional that accepts a bribe and the company representative that pays a bribe.
The new § 299a StGB is crafted very broadly and appears like a “catch-all” rule. It sanctions the improper influencing of a healthcare professional’s decision-making on the use or prescription of a certain product. Further, the new rule would also sanction “violations of professional duties” by healthcare professionals if induced by bribes from a company. However, the law does not define which “professional duties” are meant and will become subject to the law. Obviously, the broad term “professional duties” leaves room for interpretation and uncertainty that increases the legal risks for all stakeholders.
This new legislation was originally supposed to fill a gap in the German Criminal Code after in 2012 the German Federal Supreme Court (BGH) found that doctors licensed in the statutory healthcare system (Vertragsärzte) do not fall under the existing anti-corruption laws. In the case decided by the court in 2012, sales representatives of a drug company had made revenue-based payments to doctors to incentivize the prescription of their drugs. However, the now presented draft clearly goes beyond the “gap” that the court had once identified.
In conclusion, the new law bears the clear risk that many legitimate types of collaborations may be criminalized. The new law can particularly create challenges to pharmaceutical and – probably even more – for medical devices companies.
The draft legislation proposal also includes further legal amendments in the Social Security Code V that are complementary to the new § 299a StGB. The Social Security Code V is the legal basis for the German statutory health insurance system and covers approximately 90% of the German population. The envisaged amendments of the Social Security Code V aim to intensify the cooperation between health insurance funds and medical doctor associations with state prosecutors. These amendments would further intensify the control mechanisms to detect unlawful misconduct in the healthcare system. They will also impose pressure on the health insurance funds and medical doctor associations to effectively implement adequate controls and sanctions.
Overall, the new legislation proposal will now be subject to political deliberations in Germany which will take place over the next months. Pharmaceutical and medical device companies as well as other stakeholders potentially affected by the new laws should carefully monitor this process and its outcome.